Health TrialsbyHealthPanel

Nicorandil as Anti-inflammatory in Rheumatoid Arthritis

ConditionRhumatoid Arthisis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTanta University

About this trial

This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) i.e., 28 joints disease activity score (DAS-28) >2.6.

Patients receiving the conventional DMARDs

Disqualifiers

Patients with heart disease (congestive heart failure, arrhythmia and ischemic heart disease), diabetes, active infection, and other illness except rheumatoid arthritis.

Patients with severe renal and hepatic dysfunction. - Patients receiving biological DMARDs.

Patients receiving oral prednisolone greater than 15mg/day.

Patients with hypersensitivity to study medications.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Nicorandil 5 MG Oral Tablet

    Drug

    Nicorandil 5 MG Oral Tablet

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: control groupNo intervention 0 interventions
Group B: Nicorandil groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

change in 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP)

Calculation of 28-joint count Disease Activity Score (DAS28) using C- reactive protein level (CRP) where: Remission: \< 2.6. Low Disease Activity (LDA): ≤ 3.2. Moderate Disease Activity (MDA): 3.2 - 5.1. High Disease Activity (HDA): \> 5.1

Time frame
3 months
2

change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores.

Before and 3 months after the intervention, the validated Arabic Multidimensional Health Assessment Questionnaire (MDHAQ) Physical Function: Assessed through 10 activities, scored 0-3 (without difficulty=0, some=1, much=2, unable=3), with higher scores indicating worse function

Time frame
3 months

Secondary outcomes

1

The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG) at baseline and after 3 months.

Blood samples will be collected at baseline and after 3 months

Time frame
3 months
2

The change in the serum level of Interleukin 6 (IL-6) at baseline and after 3 months .

Blood samples will be collected at baseline and after 3 months

Time frame
3 months
3

The change in the serum level of C- reactive protein (CRP) at baseline and after 3 months.

Blood samples will be collected at baseline and after 3 months

Time frame
3 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Tanta University

Lead sponsor

Source ClinicalTrials.gov
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